Personalized Repetitive Transcranial Magnetic Stimulation (PrTMS) for Treatment of Post-Traumatic Stress Disorder (PTSD)

Mass General Brigham

Status: Not yet enrolling

Conditions: Posttraumatic Stress Disorder (PTSD)

Treatments: Device: Transcranial Magnetic Stimulation Sham; Device: Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07526285

2025P003206

Details and patient eligibility

About

This study is testing a personalized form of brain stimulation called PrTMS as a treatment for post-traumatic stress disorder (PTSD) in military service members and veterans. Unlike standard approaches, this treatment uses a simple brainwave test (EEG) to tailor the therapy to each individual. Participants will be randomly assigned to receive either active treatment or a comparison (sham) treatment over 6 weeks. Researchers will track changes in PTSD symptoms, mood, sleep, and overall well-being, including using wearable devices to measure things like sleep and heart rate. The goal is to see whether this personalized approach can provide greater and longer-lasting relief for individuals living with PTSD.

Full description

This study is a randomized, double-blind, sham-controlled trial evaluating a personalized approach to repetitive transcranial magnetic stimulation (PrTMS) for the treatment of post-traumatic stress disorder (PTSD) in military service members and veterans. PrTMS integrates spectral electroencephalography (sEEG) with neurocognitive assessments to individualize stimulation parameters, including frequency and intensity, and to allow for dynamic adjustment over the course of treatment based on each participant's evolving neurophysiological profile. Participants will undergo a 6-week treatment protocol (5 sessions per week), followed by longitudinal assessments over 6 months to evaluate durability of response. Multimodal outcomes will include clinician-administered and self-report measures of PTSD, mood, anxiety, and sleep, as well as physiologic and behavioral data collected via wearable devices. This study is designed to determine whether EEG-guided, precision neuromodulation improves clinical outcomes compared to standard, non-personalized stimulation approaches and to inform the development of individualized treatment strategies in PTSD.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Reserve or former member of the military (veteran status)
• Age 18 years or older
• Primary diagnosis of post-traumatic stress disorder (PTSD) confirmed by the - Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
• Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5) score ≥ 33, indicating clinically significant PTSD symptoms
• Proficient in English (spoken and written) to ensure understanding of study procedures and informed consent

Exclusion criteria

• History of open-skull traumatic brain injury
• Clinically significant seizure disorder or history of manic episodes
• Neurological conditions associated with increased risk (e.g., increased intracranial pressure, brain lesions, stroke, cerebral aneurysm)
• Electroencephalogram (EEG) abnormalities suggesting elevated seizure risk
• Repetitive transcranial magnetic stimulation (rTMS) within 3 months prior to screening
• Current use of antipsychotic or anticonvulsant medications
• Presence of intracranial implants or non-removable metal in or near the head (excluding the mouth)
• Clinically significant or unstable medical conditions, including active suicidal ideation
• Uncontrolled medical illness (e.g., thyroid, hepatic, cardiac, pulmonary, or renal disease)
• Initiation of PTSD-specific treatment within the past 4 weeks (participants on a stable regimen may be eligible)
• Pregnancy (for women of childbearing potential)
• Any condition that, in the opinion of the investigator, may interfere with study participation or completion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Active PrTMS (EEG-Guided rTMS)

Active Comparator group

Description:

Participants receive personalized, EEG-guided repetitive transcranial magnetic stimulation (PrTMS) administered 5 days per week for 6 weeks, with stimulation parameters individualized and adjusted over time based on serial sEEG and neurocognitive assessments.

Treatment:

Device: Transcranial Magnetic Stimulation

Sham PrTMS

Sham Comparator group

Description:

Participants receive sham repetitive transcranial magnetic stimulation (rTMS) administered 5 days per week for 6 weeks using a sham coil that mimics the sound and sensation of active treatment without delivering a therapeutic magnetic field.

Treatment:

Device: Transcranial Magnetic Stimulation Sham